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| Product NDC Code | 69396-057 | ||||
|---|---|---|---|---|---|
| Drug Name | Itch relief |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 106258 | ||||
| Application Number | part348 | ||||
| Labeler Name | Trifecta Pharmaceuticals USA LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Hydrocortisone 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions For itching or skin irritations, inflammation, and rashes. Adults and children 2 years and older Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age ask a doctor. For External and Anal Itching Adults: When practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily Children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aloe Barbadensis leaf juice, cetyl alcohol, Dimethicone, EDTA, Ethylparaben, Ginger Oil, Glycerin, Glyceryl stearate, Maltodextrin, Methyl gluceth-20, Methylparaben, Methylpentadecane, petrolatum, 2- Phenoxyethyl alcohol, Polysorbate 80, Propylene glycol, purified water, Stearic acid, Trisodium citrate dihydrate, Vitamin E.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For temporary relief of itching associated with minor skin irritataions, inflammation and rashes due to Eczema Insect bites poison ivy poison oak poison sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis sunburn temporarily relieves external anal and genital itching. Other uses of this product should be only under the advice and supervision of a doctor
Purpose
Information about the drug product’s indications for use.Purpose Anti-itch
Spl product data elements
Usually a list of ingredients in a drug product.Itch Relief Hydrocortisone 1% 3-METHYLPENTADECANE DIMETHICONE PHENOXYETHANOL PROPYLENE GLYCOL ALOE VERA LEAF METHYLPARABEN GLYCERYL MONOSTEARATE PETROLATUM WATER HYDROCORTISONE HYDROCORTISONE STEARIC ACID TRISODIUM CITRATE DIHYDRATE .ALPHA.-TOCOPHEROL GLYCERIN GINGER OIL MALTODEXTRIN CETYL ALCOHOL EDETIC ACID METHYL GLUCETH-20 ETHYLPARABEN POLYSORBATE 80
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging CVS 340113 Hydrocortisone cream
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other Information Store at controlled room temperature 20°-25°C (68°-77°F)
Other Information This product is not manufactured or distributed by Chattem Inc. distributor of Cortizone -10® Distributed By: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI. 02895 Product of China V-36756
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of Reach of Children If Swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Call 1-800- SHOP CVS
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop Using this product and ask a doctor if Conditions worsen Symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. Rectal bleeding occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this Product Avoid contact with the eyes. Do not use more than directed unless told to do so by a doctor. Do not put directly into rectum by using fingers or any mechanical device or applicator.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For External Use Only Do not use In the genital area if you have a vaginal discharge.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API